Zydus, part of the Cadila Healthcare group, on Friday said its indigenously developed COVID-19 vaccine candidate - ZyCoV-D - has successfully completed pre-clinical phase and has received permission from Indian authorities to conduct human trials. Drug Controller General of India (DGCI) VG Somani's office confirmed the same to TNM.
"Zydus has already manufactured clinical good manufacturing practice (GMP) batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects," the company said.
ZyCoV-D, developed at the company's Vaccine Technology Centre in Ahmedabad, has now received permission from the DCGI - Central Drugs Standard Control Organisation (CDSCO) to initiate phase I/II human clinical trials in India, Cadila Healthcare said in a regulatory filing.
This is the second Indian vaccine to get DCGI nod for human trials. The first one was a vaccine called Covaxin by Bharat Biotech. It was announced on Friday that the Indian Council of Medical Research wants to launch the Covaxin for public use by August 15, after the completion of all clinical trials.
When it comes to the Zydus vaccine, animal studies found to that it was eliciting a strong immune response in multiple subjects like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralisation assay indicating the protective potential of the vaccine candidate, it said.
It further said no safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic.
Zydus said, with its ZyCoV-D, it has successfully established the DNA vaccine platform in India using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe.
The company claimed that the vaccine candidate has no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements.
It is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest parts of the country, it said.
"Furthermore, the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection," it added.
The company now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.
(With PTI inputs)